FDA proposes stricter safety rules for plastic mesh

Washington – The Food and Drug Administration is seeking stricter safety rules for makers of the pelvic mesh device. As reported by the Associated Press (AP), in accordance with a federal proposal issued on Tuesday, plastic mesh used in the repair of pelvic collapse should be classified as “high risk” due to reports of health complications associated with the medical device over the course of several years.

As noted in the report, the proposal has been made three years after the agency concluded that women who undergo traditional surgery with stitches have fewer complications than those who are treated with the mesh. The proposal does not include mesh products used in the treatment of conditions unrelated to women’s health.

William Maisel, chief scientist for the FDA’s device center, is quoted by the AP as stating of the proposal, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.”